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NCT00782184

A Randomized, Double-Blind, Active-Controlled Study of Patients With Primary Hypercholesterolemia and High Cardiovascular Risk and Not Adequately Controlled With Atorvastatin: A Comparison of Switching to a Combination Tablet Ezetimibe/Simvastatin Versus Doubling the Baseline Dose of Atorvastatin

Completed Phase 3 Results posted Last updated 8 May 2024
What this trial tests

Phase 3 trial testing ezetimibe/simvastatin 10/40 in Hypercholesterolemia in 250 participants. Completed in 1 September 2010.

Timeline
1 November 2008
Primary endpoint
1 September 2010
1 September 2010

Quick facts

Lead sponsorOrganon and Co
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment250
Start date1 November 2008
Primary completion1 September 2010
Estimated completion1 September 2010

Drugs / interventions tested

Conditions studied

Sponsor

Organon and Co — full company profile →

Who can join

Adults 18 to 79, any sex, with Hypercholesterolemia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

Participants currently taking atorvastatin 20 mg will be switched to either atorvastatin 40 mg or ezetimibe/simvastatin 10 mg/40 mg (10/40). After 6 weeks of treatment, the percent reduction in low-density lipoprotein cholesterol (LDL-C) will be assessed and compared between the two treatment groups.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Ezetimibe/simvastatin 10/40 mg versus atorvastatin 40 mg in high cardiovascular risk patients with primary hypercholesterolemia: a randomized, double-blind, active-controlled, multicenter study.
    Hing Ling PK, Civeira F, Dan AG, Hanson ME, et al · · 2012 · cited 9× · PMID 22293030 · DOI 10.1186/1476-511x-11-18

Verify or expand the search:

Other recruiting trials for Hypercholesterolemia

Currently open trials in the same condition.

Other Organon and Co trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00782184.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing